Opening Doors of Opportunity - USC Regulatory Science

OPENING DOORS OF OPPORTUNITY

ADVANCE YOUR CAREER, IMPROVE THE WORLD

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Almost every day, a former student contacts me to share their excitement about what they’ve been doing in their career. Watching them be delighted with the way their life is evolving, and knowing you’ve helped open doors for them, is the most rewarding part of what we do.”

FRANCES RICHMOND, P h D

Chair and Founder, USC Department of Regulatory and Quality Sciences

HIGH DEMAND, REAL IMPACT

Regulatory science experts shepherd life-improving — and often lifesaving — advances from the first spark of inspira tion to the marketplace, reaching those in need. This rapidly growing and increasingly global field encompasses every aspect of pharmaceutical and medical device devel opment, quality assurance and clinical trials oversight.

Regulatory science presents exciting careers at the intersection of science, business and law that bridge the public and private sectors. Professional training in this vast and vital sphere prepares you for stimulating and rewarding jobs in which you can have a real impact on national and global health.

With our pioneering and comprehen sive curriculum, the USC Department of Regulatory and Quality Sciences is internationally renowned for preparing new leaders in this dynamic industry. We offer the big-picture foundation, hands-on skill development, global network and flexible learning options that position you for a versatile and fulfilling career as you continue to advance within the field.

Percentage anticipated growth in need for regulatory professionals annually through 2026, with future demand expected to rise further as applicable laws become increasingly complex and global markets continue to grow

Percent of graduates employed in their MS field (plus 5% going on to pursue doctoral degrees) within six months

Employers

» Industry—pharmaceutical, biotech, medical devices, startups, cosmetics, food

» Government agencies—national and international

» Universities

» Hospitals and clinical settings

» Consulting firms

“ USC was my number one choice for a regulatory science program. It is the perfect program for anyone who wants to combine business, healthcare and management into one degree with many career opportunities.”

AASHREY K. MS in Regulatory Science

PIVOTAL ROLES, VAST POTENTIAL

Regulatory and quality management experts play pivotal roles at the center of the life sciences industry, interfacing with every operational segment. They are essen tial to developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of all products regulated by the U.S. Food and Drug Administration (FDA) and its international counterparts. As these agencies exercise broad oversight over increasingly complex products, regulatory and quality specialists assure safety and effectiveness throughout these products’ entire life cycles.

In the 1980s and 1990s, people working in regulatory science usually learned on the job, gradually building expertise. Today’s fast pace of innovation and personalized medicine demands specialized training to keep ahead of evolving trends — especially as many established leaders retire. Many more jobs are available than can be filled by the current pool of skilled professionals. With the cost of securing FDA approval and bringing a drug to market estimated at some $2.6 billion, significant competition exists for attracting top talent.

While a science, pharmacy or medical background is valuable, students also come to us from such fields as business, communications, engineering, international relations, government and law. The regula tory sciences field is intensely interdisci plinary and collaborative, and those with the drive to contribute to and lead teams will find a world of opportunity.

FDA-Regulated Sectors

The FDA oversees the following broad areas of regulation, which account for about 20 percent of the economy — $2.4 trillion each year:

» Food

» Prescription and over-the-counter medications » Medical devices » Biologics

Vaccines

Cellular and gene therapies

Stem cell therapies

Blood and tissue products

» Radiation-emitting electronics » Cosmetics

» Dietary and nutritional supplements » Veterinary products » Tobacco

Sample Job Categories

The FDA offers employment in more than 30 distinct disciplines, and oppor tunities within industry can be even more varied. The following are but a few of the broad range of job categories within regulatory and quality sciences:

» Business development/corporate strategy

The MS program has shown me that there are alternative career paths to just being a business person, a pharmacist or a researcher. This combines all my interests — regulations, diplomacy, business and science — into one. The program is very accommodating of the working professional’s life and schedule.

» Government affairs and policy » Research and development » Clinical trials management » Risk management » Quality assurance and control » Good manufacturing processes » Quality system regulation » Domestic and international compliance » Supply-chain management » Project management » Drug safety » Marketing » Medical writing

» Post-marketing surveillance » Comparative effectiveness » Reimbursement

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As a postdoctoral scholar and research associate at the USC School of Pharmacy, I’m so inspired by this program that I want to change my field to regulatory science, where I can apply my knowledge and scientific background to develop a drug and design the contours so it can get to market faster.

DIPANKAR C., Ph D MS in Regulatory Management

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AMELIA S.

MS in Regulatory Science Graduate Certificate in Preclinical Drug Development

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BREADTH AND DEPTH

The USC Department of Regulatory and Quality Sciences was one of the nation’s first programs in this arena, established in 1999 in response to industry demand and with input from regulators and leading companies. We continue pioneering new opportunities to push the field forward while paving new routes to success for students and working professionals.

From undergraduate courses to graduate certificates and master’s to doctoral degrees, USC offers the full spectrum of learning opportunities for regulatory and quality sciences.

Each of our four interdisciplinary master’s programs provides the intensive preparation, hands-on learning and access to experts that build your knowledge, your network and your career:

» MS in Regulatory Science (including a progressive degree that allows undergraduates to earn their bachelor’s and MS degrees simultaneously)

» MS in Management of Drug Development

» MS in Medical Product Quality

» MS in Regulatory Management

I did my undergrad in business administration and also studied at the Culinary Institute of America. Regulatory science really brings together business development and product development, as well as the legal aspects of what is actually necessary to bring a product to market and into consumers’ hands. This program really brought together my business degree, my interest in science and my love of food.

PHILIPPOS P. MS in Regulatory Science

In 2008, we launched the nation’s first professional Doctor in Regulatory Science (DRSc), which gives mid-career professionals advanced training for global careers in both government and industry settings as well as the more traditional PhD trajectory of scholarly and academic roles.

Our Graduate Certificates include:

» Medical Product Quality

» Clinical Research Design and Management

» Food Safety

» Patient and Product Safety

» Preclinical Drug Development

» Regulatory and Clinical Affairs

At the undergraduate level, we offer:

» Minor in Science and Management of Biomedical Therapeutics

» Major in Pharmacology and Drug Development

Learn more about our programs in the accompanying inserts.

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In the USC regulatory science program, you get an overarching perspective. You learn about drugs, devices, quality and where regulatory affairs and compliance meet. The faculty are so supportive, and I love the fact that they came from industry and have 20-plus years of experience. USC offers unparalleled networking opportunities.

KAITLYN D. MS in Regulatory Science/PharmD

FLEXIBLE AND INDIVIDUALIZED

In keeping with the versatility of regulatory and quality sciences as a career path, our programs emphasize flexibility and custom ization. They are tailored to accommodate busy professionals and designed to meet your current needs and long-term goals. You set your own pace, taking the number of classes you prefer, when and where you need them — on weekends and evenings, online, in the classroom or in a blended format. Class sizes are kept intentionally small to foster networking and group interactions.

Individual classes can also be taken without enrolling in a graduate program. If you later choose to apply and are accepted, the coursework you have completed prior to admission will count toward your graduate certificate or master’s degree. And as you continue to progress in your career, you can come back and earn your doctorate.

We focus on the whole person, individualizing your experience in the program and helping you forge a career path that’s suited to you alone. You’ll have the chance to take advan tage of unique training opportunities through industry, government and other internships.

Whether you are working, seeking a gap-year experience or pursuing full-time studies, we have a program for you!

Distance Learning

Our online courses feature:

» Live lectures with professors and industry experts

» The same accessibility to lectures and course materials as the on-site program

» Frequent communication with fellow students and faculty

» Dedicated technical support ensuring a user-friendly experience

» Networking opportunities in a competitive industry

Internship Opportunities

Our students are prized by leading corporations and governmentsector employers. The program’s reputation for excellence generates internship opportunities with such organizations as:

AMGEN ALLERGAN EDWARDS LIFESCIENCESFOODANDDRUGADMINISTRATION JOHNSON&JOHNSONMEDTRONIC PFIZER STRYKER

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The program’s flexible schedule and class structure make it possible to enroll even if you’re in a full-time role somewhere else. Another reason I love the program is the support they give to both current students and alumni.

MELEENEH D.

Principal Regulatory Documentation Scientist, Genentech

Certificate in Clinical Trial Design and Management, 2010 PhD, Genetic Molecular and Cellular Biology, 2010

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The faculty are very caring, and they help you along the road with a lot of advice and point you to new opportunities. I’ve presented my research results at multiple national conferences. And you can take a trial course to see if the program is right for you before you make a full commitment and apply.

NORA Z. MS in Management of Drug Development

RIGOROUS AND INTERDISCIPLINARY

Our world-renowned faculty combine industry experience with academic excel lence. All have earned advanced degrees in regulatory science and related disciplines. Students also benefit from the insight and knowledge of outstanding speakers who have worked at the highest levels in the public and private sectors. Whether core faculty, adjunct professors or guest lecturers, these experienced leaders become part of your professional network.

Mirroring the working environment of the industry, our programs emphasize collaborative problem-solving, communi cation, teamwork, cross-functional fluency and other soft skills essential for success in all aspects of the field — from shaping individual company strategies to ushering in systemic change to advance the entire profession. We also focus on regional and cultural sensitivities, comparative regula tions and other knowledge critical for the rapid globalization of regulatory science.

USC Advantages

The Department of Regulatory and Quality Sciences has a long track record of putting our students on the path to long-term success, with benefits including:

» Outstanding faculty

A diversity of individuals all with 20+ years of industry experience who remain active in the field

» Compelling guest speakers Subject-matter experts sharing their experiences in industry and government

» Unique relationships

Long-term relationships with private and publicsector employers offering multiple opportunities for internships and jobs

» Exciting employment opportunities

90% of graduates employed in their MS field (plus 5% going on to pursue doctoral degrees) within six months (100% placement at the one-year mark)

» Strong earnings

Of students who had not previously worked in regulatory science: 48% earned between $50K and $75K in their first job 33% earned between $75K and $100K in their first job

18% earned more than $100K in their first job

EVERY MAJOR PHARMACEUTICAL COMPANY EMPLOYS AT LEAST ONE USC REGULATORY SCIENCE GRADUATE — AND USUALLY MANY.

Prior to USC, I worked at the Taiwan FDA as a reviewer of medical devices. I got my first master’s degree in biomedical engineering, so with the MS in regulatory science from USC, I have gained the bigger picture — not just of medical devices but also pharmaceuticals and biologics.

ERIC L. MS in Regulatory Science

I can’t speak highly enough of this program. I got my first job after attending a panel of industry professionals giving advice to students. Now I’m back to recruit new talent. As a graduate myself, I know the coursework and its rigor, and the emphasis on applying your knowledge.

ROSANNE M.

Director of Regulatory Affairs, Johnson & Johnson Surgical Division

MS in Regulatory Science, 2010 PhD, Genetic Molecular and Cellular Biology, 2010

Certificate in Clinical Trial Design and Management, 2010

Our students gain hands-on experience in project design, execution and management. Through the Team-based Regulatory and Quality Solutions (TRAQS) program, inter disciplinary teams of students collaborate to solve a real-world challenge posed by a leading company.

Sample Courses

Among the many courses you can choose from are:

» Regulation of Pharmaceutical and Biological Products

» Regulation of Medical Devices

» Regulation of Food and Dietary Supplements

» Quality Systems and Standards

» Biomedical Commerce (Business)

» Medical Products and the Law

» Clinical Trials

» Writing Regulatory Drug Submissions

» Global Regulation of Medical Products

» Industrial Approaches to Drug Discovery

» Risk Management for Health Products

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LIFELONG, GLOBAL NETWORK

The Trojan Family is legendary, with good reason. Our motto, “lifelong, worldwide” reflects the longstanding commitment of USC graduates to supporting new generations of Trojans as well as the network’s extension to every corner of the globe. Alumni serve as mentors, career coaches and guest lecturers. They identify employment opportunities for students and fellow graduates and participate in our frequent career fairs — often hiring students as interns and graduates for permanent positions.

Our intimate class sizes foster bonds among fellow students and faculty. Many of your classmates have extensive experience in the industry, so you also have the chance to learn from their unique backgrounds and insights. Faculty are eager to mentor and support students on their path to success.

USC’s strong worldwide presence is also an asset to our students and alumni as the demand for regulatory professionals with an international perspective continues to grow.

USC has a really good reputation around the world. The program provides a lot of opportunities — from career fairs to expert guest speakers from industry. Being able to meet all these people while a student is one of the best things about this program.

Our classmates also bring unique perspectives from their own experience working for different companies.

GINA L.

MS in Regulatory Science/PharmD

International Powerhouse

In addition to our topflight educational initiatives, USC Regulatory and Quality Sciences maintains:

» An extensive global outreach and support program — including formal partnerships in China, Korea and Taiwan, as well as frequent exchange trips and visits from foreign regulatory experts

» A hub for research groups that develop new products for unmet medical needs

» An affiliation with the Southern California Clinical and Translational Sciences Institute , which focuses on improving health outcomes for diverse communities

» The Regulatory Science Consulting Center enabling students to build expertise by working alongside faculty and other specialists, helping innovators navigate regulatory matters

» The USC-APEC Center of Training Excellence in Medical Devices , educating regulators in harmonized standards and practices

alumni

Our D.K. Kim International Center for Regulatory Science provides opportunities for global exposure and outreach, including involvement with underserved communities and inter national student groups. The Center is cultivating a diverse, new generation of leaders who can translate scientific findings into novel lifesaving drugs and medical devices that meet the needs of patients everywhere. Its ultimate mission is to offer a world-class training ground for talented profes sionals engaged in the development and commercialization of regulated products throughout the world.

USC Regulatory Science alumni (as of July 2019)

“ Our regulatory science classes are very interactive, and the faculty provide opportunities for us to enhance our experience with industry-oriented knowledge so we can end up with great jobs.

AMOOLYA G.

international offices

Certificate in Medical Product Quality

MS in Medical Devices and Diagnostic Engineering, USC Viterbi School of Engineering

international alumni clubs

LOOKING AHEAD

The USC Department of Regulatory and Clinical Sciences was built to address the capabilities and core competencies that will be needed by our society in the years ahead. That forward-looking approach guides us every step of the way as we continue to devise innovative ways to foster new genera tions of leaders. We prepare you for continual growth and advancement, in a profession that is shaping our world for the better.

People are drawn to the regulatory and quality sciences because of the outsized impact an individual can make. Instead of treating one patient at a time, you can help thousands over the lifetime of a new drug or medical device. Rather than being isolated in a laboratory, you can collaborate with a team to propel a breakthrough along the pipeline, while ensuring its safety and efficacy.

If you share a commitment to innovation and a desire to improve the lives of people every where, we can help you on your journey.

“ There’s a very close relationship between students and professors, and that’s something that I think is really unique. And I really like the network that I’m building with my classmates. I think that’s going to be the most valuable thing about this program 20 years from now.

We look forward to hearing from you.

“ What I love about this program is that everything that I learned here was immediately transferable to my job. Even though I had industry experience, I benefited from all the different types of knowledge shared by the professors.

NATASHA P. MS in Management of Drug Development, 2018

MICHAEL S. MS in Regulatory Science